FDA Registration
Active
🇨🇭 Switzerland
Faros
Reg #: 8030967
·
FEI: 1000640985
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- OERTLI INSTRUMENTE AG
- Registration Number
- 8030967
- FEI Number
- 1000640985
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- HAFNERWISENSTRASSE 4
- City
- BERNECK Sankt Gallen
- Country
- CH
Regulatory Submissions
- 510(k) Number
- K233398
Owner / Operator
- Firm Name
- OERTLI INSTRUMENTE AG
- Operator Number
- 8030967
- Address
- HAFNERWISENSTRASSE 4
- City
- BERNECK
- State
- Sankt Gallen
- Postal Code
- CH-9442
- Country
- CH
US Agent
- Business Name
- Registrar Corp
- Contact Name
- David Lennarz
- Address
- 144 Research Drive
- City
- Hampton
- State
- VA
- ZIP
- 23666
- Country
- US
- [email protected]
- Phone
- 757 2240177
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Instrument, Vitreous Aspiration And Cutting, Ac-Powered | HQE | Class 2 | Ophthalmic | No | 2024-11-27 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2024-11-27 |
| Unit, Phacofragmentation | HQC | Class 2 | Ophthalmic | No | 2024-11-27 |
Proprietary Names
Faros
Establishment Types
Manufacture Medical Device